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Reglan FDA warning

Wed, 08/31/2011 - 11:13 — matt

Many EA/TEF patients are diagnosed with GERD (gastroesophageal reflux disease), and Reglan is a common drug prescribed. The following is a US FDA warning about Reglan, which may affect some people. Please talk to your doctor about any questions you may have.

Reglan and Nervous System Disorder
On Feb. 26, 2009, FDA warned against the long-term use of drugs that contain Reglan (metoclopramide).

Metoclopramide is approved for the short-term (no longer than 3 months) treatment of gastrointestinal disorders, such as gastroesophageal reflux disease (GERD) in people who haven’t responded to other treatments, and to treat diabetic gastroparesis (slowed emptying of the stomach’s contents into the intestines).

The drug is available in a variety of formulations including tablets, syrups, and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection.

Adverse events: Frequent and long-term use of metoclopramide has been linked to tardive dyskinesia, a disorder that causes uncontrollable, repetitive movements of the body such as lip smacking, grimacing, tongue protrusion, puckering and pursing of the lips, rapid eye movements or blinking, and rapid movements of the fingers, arms, legs, and trunk.

People at risk: Those at greatest risk include elderly people, especially older women, and people who have been on the drug for a long time.

Recommendations:

Talk to your doctor before you use metoclopramide.

Avoid using the drug for a long time in all but rare cases where you and your doctor decide that the benefits outweigh the risks.

FDA actions: FDA is requiring that the drug label carry a boxed warning about the risks of using metoclopramide for a long time or at a high dose. Manufacturers must ensure that patients are given a medication guide that discusses the risks of the drug each time they receive this medication from a pharmacy.